510(k) K031297 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
ACCESS OV MONITOR ASSAY
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, May 2, 2003 |
| Received | Apr 24, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031297
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.